None listed
Conditions
Brief summary
Justification for the project: Birth plans are conceptually compelling as a safe motherhood strategy to increase killed care at delivery and immediately after, but robust empirical evidence is lacking to support their effectiveness. The proposed study meets the United Nations Depelopment Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) research objectives of improving maternal and perinatal health by generating evidence of effectiveness of interventions currently promoted through providing evidence for the effectiveness of birth plans (or lack thereof) to increase skilled care at delivery and after delivery as a strategy to reduce maternal and perinatal mortality. Proposed Research: In most developing countries including Tanzania, many more women attend antenatal care than deliver under care of skilled providers in health care settings. Having skilled delivery care providers at birth provides prompt and effective way of managing serious complications as they arise in order to reduce most maternal deaths. Birth plans are one of the components of focused antenatal care in many developing countries and is promoted as a strategy to increase skilled care at delivery. However, robust empirical evidence lacks to support the effectiveness of birth plans to increase skilled delivery care. A cluster randomized controlled trial will be conducted in 18 health units involving at least 760 women in Ngorongoro district, rural Tanzania to determine the effectiveness of birth plans in increasing skilled care at delivery and after delivery. 18 health units will be randomly assigned to provide antenatal care with renewed emphasis in birth plans (intervention) provided by care providers or control (antenatal care as currently provided). The district has over 6000 annual deliveries. Women will be interviewed twice, at first encounter and one month after delivery. Variables to be collected will be on sociodemographic characteristics, obstetric history (past and present), components of antenatal care provided, barriers to skilled delivery care utilization and care satisfaction. The primary outcome will be the proportional of women who will seek delivery at the available health units. The proportion of women who will seek post delivery care and care satisfaction as measured on a five point Likert’s scale will be the secondary outcomes.
Interventions
Antenatal care model in which birth plans will be introduced, promoted and emphasized in the intervention health units during antenatal clinic visits through provider- participant dialogue and will be performed during routine antenatal care visits as per national guidelines (attendance four times in pregnancy for women with no pregnancy complications –preferably the first visit before 16 weeks, second visit at around 28 weeks, 3rd visit between 32-34 weeks and the 4th visit at around 36 weeks).
Antenatal care model in which birth plans will be introduced, promoted and emphasized in the intervention health units during antenatal clinic visits through provider- participant dialogue and will be performed during routine antenatal care visits as per national guidelines (attendance four times in pregnancy for women with no pregnancy complications –preferably the first visit before 16 weeks, second visit at around 28 weeks, 3rd visit between 32-34 weeks and the 4th visit at around 36 weeks). Parallel to the national level, the median gestation age at first antenatal attendance is at six month and it is thus expected that most women will attend three times at most: initial visit at six months, second visit between seven and eight months and the last at nine months. The consultation time for each woman will be approximately 40 minutes at initial attendance and for approximately 15 minutes during the subsequent visits. The provider-participant dialogue will be on preparations for normal birth by identifying a skilled birth attendant and place of delivery, transport arrangement to reach the place of delivery or emergency care, financial arrangements to pay for transport and services, knowledge of where and to whom to go for help. The other discussions will be on the knowledge of danger signs during pregnancy, labour, delivery and postpartum for the mother and newborn and when to seek help when a complication arises, support in looking after the home and children while the woman is away, identification of a birth companion and identification of compatible blood donors. The dialogue will be on-going throughout the attendances and will start during the initial visit and end at the last visit when plans that have been formulated and those that have been completed will be documented by the care provider. Participants’ male partners will also be invited to participate in the dialogue. Two copies of the formulated/completed plans will be made and one given to the woman to keep and show up at a health unit she will seek delivery care. The remaining copy will be kept by the provider.
Sponsors
World Health Organization
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes
Inclusion criteria
All pregnant women attending antenatal care at health units in the district who will consent to participate in the study and meet the inclusion criteria of confirmed pregnancy by clinical palpation, resident of the district, those planning to deliver in the district and those not already referred to the available hospitals for specialized care for various reasons.
Exclusion criteria
Pregnant women with a gestational age beyond 34 weeks and/or women planning to deliver outside the district.
Outcome results
None listed